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Research Article

The Concept of Equilibrium Temperature Time Equivalents in Accelerated Stability Testing: a New Mathematical Formulation and its Effect in Pharmaceutical Product Development

Pages 371-382 | Published online: 20 Oct 2008
 

Abstract

Borrowing the mathematics used in the nonisothermal kinetic method, a new and simpler mathematical treatment of the concept of the Equilibrium Temperature Time Equivalents (ETTE) is presented. The effect of the ETTE in the pharmaceutical product stability assessment is discussed. The analysis shows that due to the stability characteristics of most drug candidates, the ETTE has very little effect on the stability data treatment.

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